510(k) K060123
K060123 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "LEVELERT II FLUID LEVEL SENSOR". The FDA issued a decision of Substantially Equivalent on February 14, 2006. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2006
- Date Received
- January 18, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Electric For Gravity Flow Infusion Systems
- Device Class
- Class II
- Regulation Number
- 880.2420
- Review Panel
- HO
- Submission Type